MPJE + Oklahoma questions with verified correct
answers
Pre-clinical (Is it safe?) - CORRECT ANSWERS ✔✔- Drug safety testing on animal
(Manufacturer can only file an *investigational new drug (IND)* to FDA for
permission to begin clinical studies phase I if the pre-clinical animal research
appears to indicate a relatively safe drug with a potential therapeutic use.)
Phase I Clinical Trial (Is it safe for human?) - CORRECT ANSWERS ✔✔- Study on
small number of healthy subjects (20-80) to determine if drug is safe.
- The safety of drug is studied on:
+ Side effects, Adverse event
+ Pharmacokinetics
+ Pharmacodynamics
Phase II Clinical Trial (Is it safe and effective for human?) - CORRECT ANSWERS
✔✔- Study about the safety and effectiveness of drug on a little bit bigger population
of real pateints (35-100)
- This study includes: safety and efficacy, dosing range.
Phase III Clinical Trial (How effective is the drug?) - CORRECT ANSWERS ✔✔-
Larger population of real patients from 300 - 3000
- Study to determine if the drug is better, safer, or more effective than a standard drug
treatment (gold-standard treatment) or placebo.
,What does the manufacturer have to do before Phase IV clinical study after the Phase
III study showed promising result? - CORRECT ANSWERS ✔✔- They need to
submit *New Drug Application (NDA)* for drug OR *Biologics License Application
(BLA)* for biologics to FDA.
- The NDA or BLA will include all:
+ Collected animal data and human data
+ Pharmacokinetic & Pharmacodynamic analysis.
+ Drug interaction studies
+ Complete review of the manufacturing process.
Who will review NDA and BLA? - CORRECT ANSWERS ✔✔- The Center for Drug
Evaluation and Research (CDER) of the FDA.
- The CDER is expected to review 90% of applications:
+ Within 10 months for *standard drugs*
+ Within 6 months for *priority drugs*
Phase IV Clinical Studies - CORRECT ANSWERS ✔✔- Post-marketing surveillance
studies that may be conducted after the drug is approved and released for use.
- The FDA might request this study to examine the risks and benefits in different
population
- The manufacturer may also conduct this study to assess such issues as the long-
term effects of drug exposure.
- The company requires to send the collected A/E reports to MedWatch at quarterly
intervals for the first 3 years after the drug approval.
Supplemental New Drug Application (sNDA) - CORRECT ANSWERS ✔✔- An
application is submitted to FDA for:
,+ Change a label
+ Add a new indication
+ Add new dosage or strength of a drug
+ Change the way it manufactures a drug.
The required categories for labeling (package inserts) - CORRECT ANSWERS ✔✔-
Indication and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Boxed Warnings if presents
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Drug interaction
- Use in Specific Populations including: pregnancy, nursing, pediatrics and geriatrics
- Description
- Clinical Pharmacology
- Clinical Studies
- References
- How Supplied/Storage and Handling
- Patient Counseling Information.
2 ways for the OTC Drug Approval Process - CORRECT ANSWERS ✔✔- New Drug
Application (NDA) process (just like new prescription drug)
- OTC monograph approval process (simpler and easier than NDA)
, OTC monograph approval process - CORRECT ANSWERS ✔✔- It has three steps
which the FDA calls a "three-phase public rulemaking process"
- Each phase requires a publication in:
+ The Federal Register
+ The Federal government's daily 'newspaper'
What happens during the first phase of OTC monograph approval process? -
CORRECT ANSWERS ✔✔- FDA advisory review panels review the active
ingredients and determine whether they are "generally recognized as safe and
effective" for use in self-treatment.
- The conclusions are published in teh Federal Register in the form of an advanced
notice of proposed rulemaking (ANPR)
- After publication of the ANPR, a period of time is given for any interested parties to
submit comments or data in response to the proposal.
What is the labeling recommends from FDA advisory review panels during the first
phase of OTC monograph? - CORRECT ANSWERS ✔✔- Therapeutic indications
- Dosage instructions
- Warnings about side effects
- How to prevent misuse.
Second Phase of OTC monograph - CORRECT ANSWERS ✔✔- Agency reviews the
active ingredients in each class of drugs, the public comments, and any new data that
has become available.
- The FDA publishes its conclusion in the Federal Register in the form of a *tentative
final monograph (TFM)*
answers
Pre-clinical (Is it safe?) - CORRECT ANSWERS ✔✔- Drug safety testing on animal
(Manufacturer can only file an *investigational new drug (IND)* to FDA for
permission to begin clinical studies phase I if the pre-clinical animal research
appears to indicate a relatively safe drug with a potential therapeutic use.)
Phase I Clinical Trial (Is it safe for human?) - CORRECT ANSWERS ✔✔- Study on
small number of healthy subjects (20-80) to determine if drug is safe.
- The safety of drug is studied on:
+ Side effects, Adverse event
+ Pharmacokinetics
+ Pharmacodynamics
Phase II Clinical Trial (Is it safe and effective for human?) - CORRECT ANSWERS
✔✔- Study about the safety and effectiveness of drug on a little bit bigger population
of real pateints (35-100)
- This study includes: safety and efficacy, dosing range.
Phase III Clinical Trial (How effective is the drug?) - CORRECT ANSWERS ✔✔-
Larger population of real patients from 300 - 3000
- Study to determine if the drug is better, safer, or more effective than a standard drug
treatment (gold-standard treatment) or placebo.
,What does the manufacturer have to do before Phase IV clinical study after the Phase
III study showed promising result? - CORRECT ANSWERS ✔✔- They need to
submit *New Drug Application (NDA)* for drug OR *Biologics License Application
(BLA)* for biologics to FDA.
- The NDA or BLA will include all:
+ Collected animal data and human data
+ Pharmacokinetic & Pharmacodynamic analysis.
+ Drug interaction studies
+ Complete review of the manufacturing process.
Who will review NDA and BLA? - CORRECT ANSWERS ✔✔- The Center for Drug
Evaluation and Research (CDER) of the FDA.
- The CDER is expected to review 90% of applications:
+ Within 10 months for *standard drugs*
+ Within 6 months for *priority drugs*
Phase IV Clinical Studies - CORRECT ANSWERS ✔✔- Post-marketing surveillance
studies that may be conducted after the drug is approved and released for use.
- The FDA might request this study to examine the risks and benefits in different
population
- The manufacturer may also conduct this study to assess such issues as the long-
term effects of drug exposure.
- The company requires to send the collected A/E reports to MedWatch at quarterly
intervals for the first 3 years after the drug approval.
Supplemental New Drug Application (sNDA) - CORRECT ANSWERS ✔✔- An
application is submitted to FDA for:
,+ Change a label
+ Add a new indication
+ Add new dosage or strength of a drug
+ Change the way it manufactures a drug.
The required categories for labeling (package inserts) - CORRECT ANSWERS ✔✔-
Indication and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Boxed Warnings if presents
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Drug interaction
- Use in Specific Populations including: pregnancy, nursing, pediatrics and geriatrics
- Description
- Clinical Pharmacology
- Clinical Studies
- References
- How Supplied/Storage and Handling
- Patient Counseling Information.
2 ways for the OTC Drug Approval Process - CORRECT ANSWERS ✔✔- New Drug
Application (NDA) process (just like new prescription drug)
- OTC monograph approval process (simpler and easier than NDA)
, OTC monograph approval process - CORRECT ANSWERS ✔✔- It has three steps
which the FDA calls a "three-phase public rulemaking process"
- Each phase requires a publication in:
+ The Federal Register
+ The Federal government's daily 'newspaper'
What happens during the first phase of OTC monograph approval process? -
CORRECT ANSWERS ✔✔- FDA advisory review panels review the active
ingredients and determine whether they are "generally recognized as safe and
effective" for use in self-treatment.
- The conclusions are published in teh Federal Register in the form of an advanced
notice of proposed rulemaking (ANPR)
- After publication of the ANPR, a period of time is given for any interested parties to
submit comments or data in response to the proposal.
What is the labeling recommends from FDA advisory review panels during the first
phase of OTC monograph? - CORRECT ANSWERS ✔✔- Therapeutic indications
- Dosage instructions
- Warnings about side effects
- How to prevent misuse.
Second Phase of OTC monograph - CORRECT ANSWERS ✔✔- Agency reviews the
active ingredients in each class of drugs, the public comments, and any new data that
has become available.
- The FDA publishes its conclusion in the Federal Register in the form of a *tentative
final monograph (TFM)*
